Transforming Psychotherapy for Chronically Ill Patients
Completed · Phase 1/Phase 2
Conditions studied: Heart Failure, Congestive, Pulmonary Disease, Chronic Obstructive, Depression, Anxiety
In brief
The primary objective of this research is to pilot test a brief mental heath treatment specifically tailored to meet the needs of chronically ill patients with anxiety and/or depression. Using an open-trial format, the proposed study will examine the feasibility of a brief psychosocial intervention. Primary outcomes will assess intervention effects on patient and clinician rated symptoms of anxiety and depression. If proven feasible and effective among this group of participants, the intervention (due to its brief format and focus on medically ill patient needs) will possess unique characteristics that will increase the ability of medical care settings to implement mental health treatments, and will provide valuable pilot data for the development of a larger research project to determine the efficacy of this intervention among a larger group of chronically ill patients relative to usual care.
Key facts
- Study ID
- NCT00520429
- Run by
- US Department of Veterans Affairs
- People needed
- 23
- Starts
- 2007-08-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2009-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Confirmation of CHF or COPD diagnosis according to medical chart review
- Ongoing symptoms of functional limitations due to CHF (NYHA classification of II , III, or IV as obtained by telephone interview) or COPD (Score of 3 or greater on the Medical Research Council Dyspnoea Scale [MRC] as obtained by telephone interview)
- Eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. Clinical cutoff scores for depression will be based on the Beck Depression Inventory - Second Edition (scores of 14 or more) while anxiety cutoffs will be determined using the State-Trait Anxiety Inventory (score of 40 or greater)
- Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.
You may not qualify if…
- History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from chart review and standardized structured clinical interview)
- NYHA class I, or MRC levels 1 and 2. Class 1 CHF patients and Level 1 and 2 COPD patients (by definition) will have no significantly limiting CHF or COPD symptoms. This information will be obtained through patient self-report of CHF and COPD symptoms
- Mental status examination score in the cognitively impaired range on an established 6-item screen
- Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning)
- Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
Where it is running
- Houston VA Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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